Infrastructure for Translational Research & Clinical Trials in India · Society for Applied Studies...
Transcript of Infrastructure for Translational Research & Clinical Trials in India · Society for Applied Studies...
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Professor N.K. Ganguly Former Director General – Indian Council of Medical Research (ICMR)
President – Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Distinguished Biotechnology Research Professor
National Institute of Immunology, New Delhi, India
ICRI 2012
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UNESCO Regional Centre for
Biotechnology (RCB)
Translational Health Science and Technology Institute
(THSTI)
VIDRC CDSA Paediatric Biology Centre (PBC)
Bio-SPACe (Planned)
Centralized Science & Technology Platform Unit
Education Research
Technology Management &
Enterprise Development
Cluster (Governance) Board
Other Cluster Partners :
Nano Science Centre
Animal Research Facility
Biotechnology Business Incubator & Biotech Park
Biodesign Centre
VIDRC: Vaccine and Infectious Disease Research Centre CDSA: Clinical Development Services Agency
NCR Health Biotech Cluster
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THSTI Niché Centres
PBC AIIMS
Biodesign Centre
Centre for population based TR
Microbial Meta-Genomics in Health &
Disease
UDSC SAS
National Biodesign Alliance
THSTI Extramural Centres
CDSA
IAVI
Bio-SPACe
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Provide cost effective, high quality preclinical and clinical product
development support services to meet the country’s growing healthcare
needs.
Interact with enterprises, particularly SMEs involved in new technology
innovation and facilitate translation of scientific know-how into viable
products.
Develop Centres of Excellence (CoE) in clinical research through
partnerships with leading institutions conducting clinical trials in India.
Provide comprehensive and sustained training in clinical research
through these COE in order to build a cadre of world class investigators
capable of conducting clinical trials for regulatory submissions.
AIMS & OBJECTIVES
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Institute for Stem Cell Biology and Regenerative Medicine (inSTEM)
◦ A new collaborative venture of DBT, which is being nurtured at NCBS.
◦ Encouraging the formation of collaborative teams to address key scientific
problems in stem cell and regenerative biology.
Centre for Cellular and Molecular Platforms (C-CAMP)
◦ A DBT initiative, also housed at NCBS, C-CAMP is envisioned to be a major
platform technology, industry-interaction and incubator unit.
◦ Enabling success in bioscience research and entrepreneurship by providing
research, development, training and service in state of the art technology
platforms.
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BSL Facilities
BSL-4
14 Facilities in Public Sector
6 more facilities planned
BSL-3
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Indian Institute of Toxicology, Pune is an independent CRO specializing in conducting Toxicology studies for pharmaceutical, agrochemical, life sciences, dyes, chemical and biotechnology companies from India and abroad.
Indian Institute of Toxicology Research (CSIR) undertakes research in niche areas of Toxicology. These include the impact of industrial and environmental chemicals on human health and ecosystem, and environmental monitoring of pollutants in air, water and soil.
12 in Public Sector; 2 in Private Sector
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National Institute of Biologicals, Noida
Central Drug Research Institute (CDRI), Lucknow
AstraZeneca Research Institute, Bangalore
Hyderabad
Bangalore
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Primate Research Center,
National Institute of
Immunology (NII), New Delhi
National Institute of
Nutrition, Hyderabad
National Institute of Cholera and
Enteric Diseases (NICED), Kolkata
Hyderabad Genome Valley,
Hyderabad
National Centre for Non-human
Primate Breeding & Research, Susnavgarh
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Shapoorji Pallonji Biotech Park, Secunderabad
Lucknow Biotech Park
Golden Jubilee Biotech Park for Women Society, Chennai
TIDCO Centre for Life Sciences (TICEL) Bio Park, Chennai
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CENTRAL UNIVERSITIES
39 existing ~20 up-coming
IISERs
• Kolkata • Trivandrum • Pune • Bhopal • Mohali
New IITs
NIPERs
• Ahmedabad • Guwahati • Hajipur • Hyderabad • Kolkata
NIT • Calicut • Durgapur
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Institute of Public Health, Bangalore
2 Centres of Excellence 4 Branches: IIPH, Hyderabad IIPH, Gandhinagar IIPH, Delhi IIPH, Bhubaneswar
Public Health Institutes
ICMR Schools of Public Health
Chennai Kolkata Pune
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National Institute of Cholera and Enteric Diseases (NICED), Kolkata
National Institute for Research in Tuberculosis (NIRT)*, Chennai
Vadu Rural Health Program, King Edward Medical (KEM) College and
Hospital, Mumbai
Postgraduate Institute of Medical Education and Research (PGI), Chandigarh
Christian Medical College (CMC), Vellore
Society for Applied Studies (SAS), Kolkata and New Delhi
Medanta Duke Research Institute (MDRI) – A Joint venture partnership between
Duke Medicine and Medanta Medicity in New Delhi – Early phase clinical site (up-
coming)
Quintiles & Apollo – Clinical Trials Unit at Hyderabad (up-coming)
* Formerly Tuberculosis Research Centre (TRC)
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Kolkata (3)
Gurgaon, HR (3)
Delhi (8)
Lucknow, UP (1)
Jaipur (1)
TOTAL : 69
Hyderabad (12)
Chennai (1)
Mumbai (17)
Bangalore (15)
CROs Noida, UP (3)
Pune (2)
Ahmedabad (3)
UP: Uttar Pradesh; HR: Haryana
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NICED-IVI / DOMI Collaborative Projects
◦ Cholera Vaccine Trials, Kolkata, West Bengal
Bivalent (01 and 0139) killed, whole cell, oral cholera vaccine
◦ Typhoid Vaccine Trials, Kolkata, West Bengal
Vi Polysaccharide Vaccine (Typherix®)
HIV/AIDS Vaccine: Phase-I Clinical Trials
◦ tg AACO9 HIV-1 Vaccine Phase 1 Trial, NARI, Pune
◦ MVA Vaccine Trial, TRC, Chennai
Rotavirus Vaccine Trial, New Delhi
◦ Neonatal Strain 116E, human rotavirus Serotype G9, P
with single gene coding VP4, isolated from AIIMS
Measles Aerosol Vaccine Phase-I Trial
Kala-azar: ICMR-DNDi VL Combo-07 Trial
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Hon’ble Former President of India, Dr. A.P.J. Abdul Kalam (1st Feb, 2005)
Inauguration of BSL-3 Facility, National Institute of Virology, Pune
by
Thank You